Cutting Costs, Not Accuracy: Pixee Medical’s AR Revolution in Orthopedic Implants

FDA clearance positions Pixee Medical’s AR Revolution as a transformative tool for the global orthopedic devices market, combining cost-efficiency and robot-level precision.

• In April 2025, Pixee Medical, a France-based leader in augmented reality navigation, received U.S. FDA approval for its advanced AR system Knee+ NexSight, designed to meet the needs of surgeons seeking high precision and efficiency in total knee arthroplasty (TKA).

Knee+ NexSight builds on Pixee Medical’s first-generation platform, which has already powered over 10,000 procedures globally. The new platform offers robotic-like implant placement precision, all without the expense, or complexity of robotic systems, thus making an alternative in an industry increasingly focused on value-based care.

A New Chapter in Orthopedic Innovation: Augmented Reality as the Operating Room Ally

In the era, where surgeons and hospitals demand cost-effective innovations that don’t compromise clinical outcomes, this platform offers delivers a solution that is both powerful and practical, helping the surgeons. Developed in collaboration with U.S. orthopedic surgeons, the system is compatible with all existing primary total knee implant systems and integrates into routine surgical workflows with minimal disruption.

The orthopedic devices market size is expected to reach USD 64 billion in 2028, and is shifting towards scalable solutions that balance innovation with economic feasibility. Knee+ NexSight helps by delivering advanced intraoperative guidance that avoids the typical costs and operational hurdles associated with robotic systems.

Surgeon Endorsed: Surgical Accuracy without the Trade-Offs

“Knee+ NexSight integrates naturally into surgeons' usual procedures, minimizing the learning curve. This innovative solution improves total knee arthroplasty outcomes while offering simple and efficient technology.”

-Dr. Scott R. Nodzo, Orthopedic Surgeon - Buffalo, NY

Scaling with Sustainability and Interoperability in Mind

By eliminating physical disposables, minimizing the environmental footprint, and offering compatibility across various implants, this platform addresses a crucial need in orthopedic device innovation: smart, efficient and green technology.

Moreover, it introduces an optional connectivity mode, making it the first AR orthopedic solution with secure data-sharing capabilities. This allows integration with third-party digital surgery platforms, thereby enabling real-time data flow, cloud-based updates and compatibility with evolving surgical software ecosystems.

Unlocking Digital-Ready Care

The approval of this Knee+ NexSight not only meets the current surgical needs but also positions providers for future data-enabled operating rooms. Its connectivity feature supports workflow automation, surgical analytics, and potential AI-driven decision-making, paving the way for digital-first orthopedic practices.

Redefining Value and Access in Orthopedic Surgery

• Cost-effective alternative to robotics

Knee+ NexSight offers robotic-like precision without high capital investment, making advanced technology accessible to smaller hospitals.

• Boosts AR adoption in orthopedic

The FDA clearance propels augmented reality as a mainstream intraoperative guidance tool, accelerating AR adoption in orthopedic devices workflows.

• Supports shift towards outpatient procedures

Its compact and disposable-free design supports the growing trend of shifting total knee arthroplasty from traditional healthcare settings to high-efficiency settings such as ambulatory surgical centers (ASCs).

• Reduce procedure costs

Eliminates the need for preoperative CT/MRI scans and disposable components, significantly lowering per-case costs and improving hospitals margins.

• Drives workflow digitization

The optional connectivity module enables real-time data sharing and seamless software updates, aligning the market shift toward digitally integrated orthopedic surgery platforms.

• Environmentally conscious innovation

By removing the need for disposable tools and minimizing waste, Pixee Medical contributes to sustainability trends within this sector.

• Democratizes Access to Precision Tools

Make high-precision guidance viable for underserved or resource-limited care settings, expanding access to quality surgical care.

Thus, as demand for efficient, value-based surgical solutions grew, Knee+ NexSight sets a new benchmark for innovation in joint replacement procedures.